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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Karl Storz Endoscopy America Inc: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Agency Publication Date: May 11, 2013
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Affected Products

Product: Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36775, 36786, 36828, 36864

Lot Numbers:
36775
Product: Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36785, 36827

Lot Numbers:
36785
Product: Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36829

Lot Numbers:
36829
Product: Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36832

Lot Numbers:
36832
Product: Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36833

Lot Numbers:
36833
Product: Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36850

Lot Numbers:
36850
Product: Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36835

Lot Numbers:
36835
Product: Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36836

Lot Numbers:
36836
Product: Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36781

Lot Numbers:
36781
Product: Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36851

Lot Numbers:
36851
Product: Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36897

Lot Numbers:
36897
Product: Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36815

Lot Numbers:
36815

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 55358
Status: Resolved
Manufacturer: Karl Storz Endoscopy America Inc
Manufactured In: United States
Units Affected: 12 products (9432 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.